QMS Documentation Lead

SaniSure; Camarillo (CA); On-site; USD 85,000 - 115,000; Full time

Job summary

SaniSure is a cutting-edge biotech manufacturer and globally active in single-use products and systems for biopharma production. We seek a Quality Systems Specialist to maintain the QMS, oversee validation guides, specs, certificates, and related records.

You will collaborate with Quality, Engineering, R&D/NPI, Regulatory Compliance, Manufacturing, and Supply Chain to ensure accurate, traceable, and compliant product information.

Qualifications

• Bachelor's degree in biological sciences, engineering, or a related technical field.
• 3+ years' experience in quality systems or controlled documentation in regulated manufacturing.
• Experience with CAPA, risk management, and audits.

Responsibilities

• Develop and maintain controlled quality and technical documentation.
• Coordinate collection of product drawings, materials, and supplier information.
• Maintain revision history and document workflow controls.
• Support internal and supplier audits and supplier qualification.
• Assist CAPA investigations and quality improvement activities.
• Respond to customer requests for regulatory documentation.

Skills

Quality systems

CAPA

Risk management (FMEA)

Document control

Technical documentation

Regulatory compliance

Education

Bachelor's degree in biological sciences, engineering, or related technical field

Job description

SaniSure is a cutting-edge biotech manufacturer and globally active in single-use products and systems for biopharma production. We seek a Quality Systems Specialist to maintain the QMS, oversee validation guides, specs, certificates, and related records.

You will collaborate with Quality, Engineering, R&D/NPI, Regulatory Compliance, Manufacturing, and Supply Chain to ensure accurate, traceable, and compliant product information.